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Renal Replacement Therapy Plus Extracorporeal Carbon Dioxide Removal

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
RRT plus ECCO2R
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring AKI, Extracorporeal Carbon Dioxide Removal, Renal Replacement Therapy, Mechanical Ventilation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with acute kidney injury (AKI) requiring renal-replacement therapy and mechanical ventilation of duration ≥ 48 hours

Exclusion Criteria:

  • little chance of survival at 24 h (according to clinical judgment), pregnancy, mechanical ventilation with expected duration lower than 48h, age under 18 and over 90

Sites / Locations

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RRT plus ECCO2R

Arm Description

Outcomes

Primary Outcome Measures

Achievement of tidal volume reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values

Secondary Outcome Measures

Evaluation of inflammatory mediators release in plasma samples of patients
Plasma Concentrations of interleukin 6, interleukin 8, interleukin 1 beta, tumor necrosis factor alpha
Assessment of the changes in pH
Assessment of the changes in PaCO2
Assessment of the changes in PaO2

Full Information

First Posted
October 30, 2015
Last Updated
December 22, 2017
Sponsor
University of Turin, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT02595619
Brief Title
Renal Replacement Therapy Plus Extracorporeal Carbon Dioxide Removal
Official Title
Combined Strategy of Renal Replacement Therapy Plus Extracorporeal Carbon Dioxide Removal in Patients With Acute Kidney Injury
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to assess whether in patients with acute kidney injury (AKI) requiring mechanical ventilation, a strategy that combines renal replacement therapy (RRT) and extracorporeal carbon dioxide removal (ECCO2R) allows reduction of tidal volume and plateau pressure. Systemic Inflammatory Response and Safety Variables will also be analysed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
AKI, Extracorporeal Carbon Dioxide Removal, Renal Replacement Therapy, Mechanical Ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RRT plus ECCO2R
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
RRT plus ECCO2R
Intervention Description
Patients with acute kidney injury will be treated with Renal replacement therapy associated to extracorporeal carbon dioxide removal in a single treatment
Primary Outcome Measure Information:
Title
Achievement of tidal volume reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Evaluation of inflammatory mediators release in plasma samples of patients
Description
Plasma Concentrations of interleukin 6, interleukin 8, interleukin 1 beta, tumor necrosis factor alpha
Time Frame
72 hours
Title
Assessment of the changes in pH
Time Frame
72 hours
Title
Assessment of the changes in PaCO2
Time Frame
72 hours
Title
Assessment of the changes in PaO2
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with acute kidney injury (AKI) requiring renal-replacement therapy and mechanical ventilation of duration ≥ 48 hours Exclusion Criteria: little chance of survival at 24 h (according to clinical judgment), pregnancy, mechanical ventilation with expected duration lower than 48h, age under 18 and over 90
Facility Information:
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Turin
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

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Renal Replacement Therapy Plus Extracorporeal Carbon Dioxide Removal

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